Bayer Purposely Does Not Disclose Trasylol Dangers

Failure by the German pharmaceutical giant Bayer to inform the Food and Drug Administration of the disquieting results of a large observational study cannot be easily dismissed with an apology. Circumstances suggest that Bayer sought to hide the results and only came clean when forced to by a whistleblower.

Trasylol has long been used in heart surgery to reduce blood loss and the need for transfusions. Although extensive data seemed to document the drug's effectiveness and safety, two studies published this year found that it increased the risk of kidney failure, heart attack, and stroke.

An F.D.A. advisory committee, after reviewing extensive data at a public meeting on Sept. 21, 2006, overwhelmingly concluded that Trasylol was still acceptably safe and effective for certain patients. Bayer representatives who participated in the meeting kept quiet about the most recent Bayer-sponsored study which raised even more questions about the drug's safety.

After the fact, a whistleblower, possibly an outside researcher, reportedly called both the FDA and only then was Bayer forced to make a full disclosure. Preliminary results of the suppressed study showed that Trasylol may increase the chance for death, serious kidney disease, congestive heart failure, and strokes.

Who can you trust? (NY TIMES)